Multicenter, Open-label, Safety and Tolerability Study

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.

Key facts

Study ID

NCT01649557

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

244

Starts

2009-08-01

Expected to finish

2011-09-01

Last updated by the study team

2015-10-29

Who can join

Age: 18 and older, up to 67. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who participated in 331-07-203 and who, in the opinion of the investigator, have the potential to benefit from continued administration of OPC-34712 for the treatment of schizophrenia.
• Outpatient status at last visit of Study 331-07-203.

You may not qualify if…

• Sexually active males who are not practicing two different methods of birth control during the study and for 90 days after the last dose of study medication or who will not remain abstinent during the study and for 90 days after the last dose, or sexually active females of childbearing potential who are not practicing two different methods of birth control during the study and for 30 days after the last dose of study medication or who will not remain abstinent during the study and for 30 days after the last dose. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injection, birth control implant, condom, or sponge with spermicide.
• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
• Subjects who during the course of their participation in 331-07-203 were treated in violation of the protocol or who developed ANY exclusion criteria during the course of their participation.
• Subjects who do not continue to meet all applicable inclusion/exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.
• Subjects who represent a risk of committing suicide based on an answer of "Yes" to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A subject who has had any suicidal ideation within the last 6 months, any suicidal behaviors within the last two years, or who in the clinical judgment of the investigator presents a serious risk of suicide should be excluded from the study.
• Subjects who would be likely to require prohibited concomitant therapy during the study.
• Any subject who, in the opinion of the investigator, should not participate in the study.

Where it is running

• Otsuka Investigational Site — Escondido, California, United States
• Otsuka Investigational Site — Garden Grove, California, United States
• Otsuka Investigational Site — Long Beach, California, United States
• Otsuka Investigational Site — Oceanside, California, United States
• Otsuka Investigational Site — Pasadena, California, United States
• Otsuka Investigational Site — San Diego, California, United States
• Otsuka Investigational Site — San Diego, California, United States
• Otsuka Investigational Site — Santa Ana, California, United States
• Otsuka Investigational Site — Washington D.C., District of Columbia, United States
• Otsuka Investigational Site — Bradenton, Florida, United States
• Otsuka Investigational Site — Maitland, Florida, United States
• Otsuka Investigational Site — St Louis, Missouri, United States
• Otsuka Investigational Site — Cedarhurst, New York, United States
• Otsuka Investigational Site — Philadelphia, Pennsylvania, United States
• Otsuka Investigational Site — Austin, Texas, United States
• Otsuka Investigational Site — Burgas, Bulgaria
• Otsuka Investigational Site — Kazanlak, Bulgaria
• Otsuka Investigational Site — Pazardzhik, Bulgaria
• Otsuka Investigational Site — Plovdiv, Bulgaria
• Otsuka Investigational Site — Radnevo, Bulgaria
• Otsuka Investigational Site — Rousse, Bulgaria
• Otsuka Investigational Site — Rijeka, Croatia
• Otsuka Investigational Site — Zagreb, Croatia
• Otsuka Investigational Site — Vijaywada, Andh Prad, India
• Otsuka Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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